Endometrial CancerFIRESNCT01673022
Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging
A study testing IC Green in people with Endometrial Cancer and Cervical Cancer, run by Indiana University at 7 sites in United States.
Trial summary
Description: This is a multi-institutional study investigating the sensitivity and negative predictive value of sentinel lymph nodes mapped with robotic assisted near infrared imaging after cervical injection of indocyanine green (ICG) dye for women with stage I endometrial or cervical cancer at the time of their… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Cervical Cancer
- What is being tested?
- IC Green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2012to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be women 18 years and older who have biopsy proven endometrial or cervical carcinoma (of any histologic subtype).
- Surgical staging with the da Vinci Si robotic tool must be planned with a planned pelvic and, in the case of endometrial cancer, a para-aortic lymphadenectomy
- Patients must meet criteria for robotic surgical approach:
- Patients must have either a clinical stage I endometrial (of any histologic grade) or FIGO stage IA2 or IB1 (<4cm) cervical squamous, adenocarcinoma or adenosquamous carcinoma.
- Patients must be able to sign an informed consent in English language.
- Patients with known liver disease will require normal range liver function tests as determined by pre-operative labs drawn within 30 days of surgery.
Who cannot join
- Patients who have iodide allergies
- Patients who have had previous retroperitoneal surgery
- Patients on whom pelvic+/- para-aortic lymphadenectomy is not planned as part of their surgical staging.
- Patients who have received previous treatment for their endometrial or cervical cancer (particularly hysterectomy or pelvic radiation).
- Patients who are pregnant.
- Patients with documented liver disease who have abnormalities of liver function tests.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Virginia Medical Center
Charlottesville, Virginia, 22903
Tri Health Good Smaritan Hospital
Cincinnati, Ohio, 45220
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017
Indiana University
Indianapolis, Indiana, 46202
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
USA Mitchell Cancer Institute
Mobile, Alabama, 36604
About this study
Official title: Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging for Detecting Metastatic Endometrial and Cervical Cancer
Description:
This is a multi-institutional study investigating the sensitivity and negative predictive value of sentinel lymph nodes mapped with robotic assisted near infrared imaging after cervical injection of indocyanine green (ICG) dye for women with stage I endometrial or cervical cancer at the time of their robotic surgical staging.
Patients will receive cervical injection of 1mg ICG after induction of anesthesia followed by sentinel lymph node mapping using robotic assisted fluorescence imaging. The sentinel lymph nodes identified will be removed and sent for ultraprocessing by pathology. The non-sentinel pelvic and para-aortic (if indicated) non-sentinel nodes will be removed and sent for routine pathologic processing according to standard of care for these surgical procedures. The pathologic results of the sentinel and non-sentinel nodes will be evaluated for sensitivity and negative predictive value in their ability to detect metastatic disease.
Read the detailed description
Brief Summary:
Patients with early stage endometrial and cervical cancer who are undergoing robotic surgery to remove the uterus, cervix and lymph nodes will have dye injected into the cervix after they are asleep from anesthesia prior to performing the surgery. During the surgery, the surgeon will activate the robotic camera that is being used to visualize the internal organs changing it to a special mode of imaging called near infrared imaging. The near infrared imaging will allow the surgeon to see where the dye that was injected into the cervix has spread. The dye travels through vessels called lymphatic channels to nodules called "sentinel lymph nodes". These are the tissues the surgeon is most interested in removing in order to see if there has been spread of their cancer to those nodules. The dye that travels to the lymph nodes makes them more easily visible to the surgeon. Without the dye, these nodes are indistinguishable from the surrounding fatty tissue.
The nodes that have dye in them will be removed from the patient and sent to the pathologist, where they will be very closely examined, called ultrasectioning, for cancer spread. The surgeon will remove the remaining lymphatic tissue (all of the fatty and lymphatic tissue that surrounded the sentinel lymph node that did not stain with the dye), as these are the "non-sentinel lymph nodes", and are the tissue that is traditionally removed with endometrial and cervical cancer surgery as part of standard of care. These non-sentinel lymph nodes will also be examined for evidence of cancer spread. The researchers will compare the pathology results from the sentinel nodes and non-sentinel nodes. The researchers hypothesize that the sentinel nodes contain cancer cells at least 90% of the time when there is cancer found in the non-sentinel nodes.
- Conditions
- Endometrial Cancer, Cervical Cancer
- Being tested
- IC Green
- Medical subject headings
- Endometrial Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IC GreenDrug
Also called indocyanine green for injection, USP
IC Green
| Study group | Role | What they receive |
|---|---|---|
| IC Green Arm | Experimental | One arm only: Receives IC Green for testing of study objective Receives: Drug: IC Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the Sensitivity of the Sentinel Lymph Node
To estimate the sensitivity of the sentinel lymph node in the determination of lymph node metastases in patients with invasive carcinoma of the cervix and uterus using Indocyanine Green (ICG) and robotic assisted near infrared (NIR) imaging. Sensitivity is defined as the proportion of sentinel lymph node: number of participants with, determined to be metastatic by both IGR/NIR and pathology out of the sentinel lymph nodes found to be metastatic by pathology.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emma Rossi, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673022
- Sponsor's protocol ID
- 1204008493
- Acronym
- FIRES
- Status last verified
- Jul 2017
- First submitted
- 22 Aug 2012
- Last updated
- 24 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rossi EC, Kowalski LD, Scalici J, Cantrell L, Schuler K, Hanna RK, Method M, Ade M, Ivanova A, Boggess JF. A comparison of sentinel lymph node biopsy to lymphadenectomy for endometrial cancer staging (FIRES trial): a multicentre, prospective, cohort study. Lancet Oncol. 2017 Mar;18(3):384-392. doi: 10.1016/S1470-2045(17)30068-2. Epub 2017 Feb 1.
PubMed 28159465
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging for Detecting Metastatic Endometrial and Cervical Cancer
- ClinicalTrials.gov ID
- NCT01673022
- Acronym / sponsor ID
- FIRES / 1204008493
- Conditions
- Endometrial Cancer, Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Posted 24 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Description:
This is a multi-institutional study investigating the sensitivity and negative predictive value of sentinel lymph nodes mapped with robotic assisted near infrared imaging after cervical injection of indocyanine green (ICG) dye for women with stage I endometrial or cervical cancer at the time of their robotic surgical staging.
Patients will receive cervical injection of 1mg ICG after induction of anesthesia followed by sentinel lymph node mapping using robotic assisted fluorescence imaging. The sentinel lymph nodes identified will be removed and sent for ultraprocessing by pathology. The non-sentinel pelvic and para-aortic (if indicated) non-sentinel nodes will be removed and sent for routine pathologic processing according to standard of care for these surgical procedures. The pathologic results of the sentinel and non-sentinel nodes will be evaluated for sensitivity and negative predictive value in their ability to detect metastatic disease.
Detailed description
Brief Summary:
Patients with early stage endometrial and cervical cancer who are undergoing robotic surgery to remove the uterus, cervix and lymph nodes will have dye injected into the cervix after they are asleep from anesthesia prior to performing the surgery. During the surgery, the surgeon will activate the robotic camera that is being used to visualize the internal organs changing it to a special mode of imaging called near infrared imaging. The near infrared imaging will allow the surgeon to see where the dye that was injected into the cervix has spread. The dye travels through vessels called lymphatic channels to nodules called "sentinel lymph nodes". These are the tissues the surgeon is most interested in removing in order to see if there has been spread of their cancer to those nodules. The dye that travels to the lymph nodes makes them more easily visible to the surgeon. Without the dye, these nodes are indistinguishable from the surrounding fatty tissue.
The nodes that have dye in them will be removed from the patient and sent to the pathologist, where they will be very closely examined, called ultrasectioning, for cancer spread. The surgeon will remove the remaining lymphatic tissue (all of the fatty and lymphatic tissue that surrounded the sentinel lymph node that did not stain with the dye), as these are the "non-sentinel lymph nodes", and are the tissue that is traditionally removed with endometrial and cervical cancer surgery as part of standard of care. These non-sentinel lymph nodes will also be examined for evidence of cancer spread. The researchers will compare the pathology results from the sentinel nodes and non-sentinel nodes. The researchers hypothesize that the sentinel nodes contain cancer cells at least 90% of the time when there is cancer found in the non-sentinel nodes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IC Green Arm | Experimental | Drug: IC GreenOne arm only: Receives IC Green for testing of study objective |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be women 18 years and older who have biopsy proven endometrial or cervical carcinoma (of any histologic subtype).
- Surgical staging with the da Vinci Si robotic tool must be planned with a planned pelvic and, in the case of endometrial cancer, a para-aortic lymphadenectomy
- Patients must meet criteria for robotic surgical approach:
- Patients must have either a clinical stage I endometrial (of any histologic grade) or FIGO stage IA2 or IB1 (<4cm) cervical squamous, adenocarcinoma or adenosquamous carcinoma.
- Patients must be able to sign an informed consent in English language.
Key exclusion criteria (6 listed)
- Patients who have iodide allergies
- Patients who have had previous retroperitoneal surgery
- Patients on whom pelvic+/- para-aortic lymphadenectomy is not planned as part of their surgical staging.
- Patients who have received previous treatment for their endometrial or cervical cancer (particularly hysterectomy or pelvic radiation).
- Patients who are pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IC GreenAlso: indocyanine green for injection, USPIC Green | Drug | IC Green Arm |
Primary outcome
Estimate the Sensitivity of the Sentinel Lymph Node
Time frame: 3 years
To estimate the sensitivity of the sentinel lymph node in the determination of lymph node metastases in patients with invasive carcinoma of the cervix and uterus using Indocyanine Green (ICG) and robotic assisted near infrared (NIR) imaging. Sensitivity is defined as the proportion of sentinel lymph node: number of participants with, determined to be metastatic by both IGR/NIR and pathology out of the sentinel lymph nodes found to be metastatic by pathology.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28159465Rossi EC, Kowalski LD, Scalici J, Cantrell L, Schuler K, Hanna RK, Method M, Ade M, Ivanova A, Boggess JF. A comparison of sentinel lymph node biopsy to lymphadenectomy for endometrial cancer staging (FIRES trial): a multicentre, prospective, cohort study. Lancet Oncol. 2017 Mar;18(3):384-392. doi: 10.1016/S1470-2045(17)30068-2. Epub 2017 Feb 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Rossi, MD principal investigator
Indiana University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IC Green in people with Endometrial Cancer and Cervical Cancer, run by Indiana University at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the Sensitivity of the Sentinel Lymph Node (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01673022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.